Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 715
- 试验地点
- 4
- 主要终点
- Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.
研究概览
简要总结
The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.
详细描述
This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents.
Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:
- •ST segment elevation >=1mm in standard leads and >=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
- •New or presumably new left bundle branch block (LBBB)
- •The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;
排除标准
- •Killip class > 2 upon arrival to the cath-lab;
- •Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
- •Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
- •Documented left ventricular ejection fraction <=30%;
- •Target lesion is located in an arterial or venous by-pass graft;
- •ECG documented evidence of prior myocardial infarction;
- •Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
结局指标
主要结局
Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.
时间窗: 1 and 6 months and at 1, 3, 4, and 5 years post-procedure.
次要结局
- recurrence of myocardial infarction(1, 3, 4 and 5 years post-procedure)
- revascularization of the target vessel (TVR)(1, 3, 4 and 5 years post-procedure)
- recurrence of ischemia(1, 3, 4 and 5 years post-procedure)
- cardiac death(1, 3, 4 and 5 years post-procedure)